Quality and Validation

An experienced consultant with a solid background in quality management systems and regulatory requirements (ISO & cGMP (21CFR 211/820/600 and EU directives for design manufacture and distribution of pharmaceuticals and medical devices

• Microsoft Access

An experienced consultant with a solid background in quality management systems and regulatory requirements (ISO & cGMP (21CFR 211 / 820/600 including part 11 and EU directives for design manufacture and distribution of pharmaceuticals and medical devices).Design controls and Industrial processes for Chemical and Biochemical production and distribution of pharmaceuticals medical devices and vaccines. Management tools, (BPR, MPR/MPRII, SAP, TEDI) manufacturing techniques, and quality management tools such as SPC, Pareto, Continuous improvement (Kaizen), Risk Management and FMEA, JIT, Kanban, Lean Manufacturing, 6 Sigma, and 5 Pillars / 5S. Experienced in the commissioning; validation and verification of complex process equipment for primary and secondary processing in Bio-pharm Pharmaceutical and Medical devices including validation of computer systems, Invitro Diagnostic Devices and Laboratory equipment and methods. Validation of instruction for use by human factors engineering studies

BSc
MCQI
CQP
MS Office / SAP / Agile /